NCT02094911Unknown不适用
Implementation and (Cost-)Effectiveness of Diabetes Prevention in Dutch Primary Health Care: From SLIM to SLIMMER
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 316
- 试验地点
- 1
- 主要终点
- Change in fasting insulin
研究概览
简要总结
The overall aim of the project is to evaluate the (cost-)effectiveness of the SLIMMER diabetes prevention intervention in Dutch primary health care.
详细描述
This is a randomised controlled trial, conducted in a real-life setting (Dutch primary health care).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-70 years
- •Impaired fasting glucose (IFG; i.e. venous plasma glucose concentration ≥6.1 and
- •≤6.9 mmol/l) during the past 5 years, according to the GP registration database OR diabetes risk score ≥7 as calculated from the Diabetes Risk Test
- •Willing and able to participate in the intervention for at least 1.5 years
- •Dutch speaking
排除标准
- •Known diabetes mellitus
- •Any chronic illness that makes 1.5-years survival improbable, interferes with glucose tolerance, or makes participation in a lifestyle intervention impossible
- •Patients with any severe cardiovascular disease (this also includes history of cardiac dysrhythmia), unless GP gives agreement
- •Medication known to interfere with glucose tolerance
- •Any mental or physical disability that will hinder participation in the lifestyle intervention
- •Severe psychiatric disease
- •Patients who showed bad compliance in the past
- •Participation in another regular vigorous exercise and/or diet programme, i.e.:
- •Intensive exercise programme: any exercise programme offered by a physiotherapist and/or patients sporting at least 3 times a week at their own initiative.
- •Intensive diet programme: patients who visited a dietician at least 3 times during the last year.
结局指标
主要结局
Change in fasting insulin
时间窗: Baseline, end of intervention (12 months), after follow-up (18 months)
次要结局
- Medication use(Baseline, end of intervention (12 months), after follow-up (18 months))
- Glucose tolerance(Baseline, end of intervention (12 months), after follow-up (18 months))
- Serum lipids(Baseline, end of intervention (12 months), after follow-up (18 months))
- Quality of Life(Baseline, end of intervention (12 months), after follow-up (18 months))
- Eating behaviour(Baseline, end of intervention (12 months), after follow-up (18 months))
- Physical fitness(Baseline, end of intervention (12 months), after follow-up (18 months))
- Blood pressure(Baseline, end of intervention (12 months), after follow-up (18 months))
- Physical activity behaviour(Baseline, end of intervention (12 months), after follow-up (18 months))
- Behavioural determinants(Baseline, end of intervention (12 months), after follow-up (18 months))
- Body fatness(Baseline, end of intervention (12 months), after follow-up (18 months))
- Process indicators(Baseline, end of intervention (12 months), after follow-up (18 months))
研究者
研究点 (1)
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